Patients presenting with COVID-19 in our hospitals will be asked to take part in our clinical trials, as we join with national and international colleagues to fight this disease.
Patients will be able to take part in a clinical trial if they meet the inclusion criteria. This means they have been identified as eligible because the trial may best help someone like them.
To help them decide whether they want to take part, a member of staff will explain to them what the study involves. They will also give the person a patient information sheet (PIS). They are under no obligation to say yes, and their standard care will not be affected if they decide not to take part.
SPRINTER (SG018)
SPRINTER is a phase III study assessing the safety and effectiveness of SNG001, a medicine delivered through a nebuliser. Eligible patients will be 18 years or over, have a confirmed positive test for COVID-19, been admitted to hospital and require low-flow oxygen, and have not previously received a COVID-19 vaccination. In phase II trials, which recruited 12 patients at UHL, the trial drug delivered promising results: patients receiving SNG001 were twice as likely to recover from COVID-19 as those receiving a placebo.
STATUS: Closed to new recruits; in follow-up
Visit: https://www.synairgen.com/programmes/covid-19/
ENSEMBLE 2
This phase 3 vaccine trial is testing the safety and effectiveness of a two-dose regimen of a new COVID-19 vaccine, which uses a weakened common cold virus and a part of the COVID-19 virus to stimulate the immune system to later fight a real infection. Recruitment is still open to people from any ethnic minority background who are between 18 and 40 years old. The study will follow the participants for up to two years and three months for signs and symptoms of COVID-19 to determine how long protection lasts.
STATUS: Closed to new recruits; in follow-up
Visit: https://local.nihr.ac.uk/prc/leicester/patients/get-involved.htm
UK-REACH
The NIHR Leicester Biomedical Research Centre is leading a UK-wide study that will investigate if, how, and why, ethnicity affects COVID-19 clinical outcomes in health and care workers. It will undertake a range of programmes, including recruiting 30,000 healthcare workers, to gain a comprehensive picture of the impact of COVID-19 on the physical and mental well-being of staff, working with organisations such as the General Medical Council and Nursing and Midwifery Council.
STATUS: Open to recruitment
Visit: https://uk-reach.org/main/https://uk-reach.org/main/
PHOSP-COVID
The Post-hospitalisation COVID-19 study is a UK wide research programme led by the NIHR Leicester Biomedical Research Centre into the long term health outcomes of patients who were hospitalised with COVID-19. Participants will have clinical assessments to help clinicians and scientists better understand the ongoing medical, psychological and rehabilitation needs for this group of patients so they can make as full a recovery as possible.
Status: open to recruitment
Visit: www.phosp.org
SIREN
This important research is focused on healthcare workers and looks at whether prior infection with COVID-19 confers future immunity against reinfection. Recruitment is across all three hospital sites. Staff taking part will be given regular antibody tests and swab tests over a 12-month period.
STATUS: closed to new recruits
Visit: PHE announcement
Vitamin D levels in COVID-19 patients
We are collecting routine clinical data on vitamin D levels for patients with COVID-19, to see if there is a connection between reduced levels of vitamin D and patient outcomes.
STATUS: closed to new recruits; in follow-up
Visit: No website available
STOP-COVID
This trial investigates whether a new medicine, Brensocatib, can help people with COVID-19. Brensocatib may help by reducing lung inflammation, which could improve symptoms for people with COVID-19 and reduce the length of time patients need to stay in hospital.
STATUS: closed to recruitment; patients in follow-up
Visit: https://stop-covid19.org.uk/
ISARIC
We are part of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). As part of this group, we are collecting clinical data and samples from patients who have confirmed COVID-19. By collecting this information we can better understand the disease and use this learning to inform treatment decisions and the wider public health response in our communities.
STATUS: open to recruitment
Visit https://isaric.org/
RECOVERY
In this clinical trial, patients with suspected or confirmed COVID-19 will be given one of a set of different medicines that have been used to treat other conditions, such as HIV, to see if they provide any benefits. This will help healthcare professionals decide if these treatments should be given in future.
This trial is open in various forms to all patients of all ages, including children and pregnant women.
This is an adaptive study, which means new therapies can be added to the trial as they become available.
TRIAL UPDATES: Hydroxychloroquine, Lopinavir-Ritonavir, azithromycin, colchicine, aspirin and convalescent plasma have been shown to confer no clinical benefit to patients. For this reason, these trial arms are no longer recruiting.
Dexamethasone has been shown to significantly improve outcomes for adult patients who require oxygen or ventilation and is now standard care for adult patients with COVID-19. The dexamethasone trial arm is now only recruiting children.
Tocilizumab has been shown to reduce death in patients hospitalised with COVID-19 and standard of care guidelines are being drawn up.
REGEN-COV (casirivimab and imdevimab) reduces deaths for hospitalised patients with COVID-19 who have not mounted their own immune response.
The baricitinib arm has just closed, with results yet to be announced.
Current trial arms are high-dose versus low-dose corticosteroids, empagliflozin (a medicine for diabetes, kidney and heart disease), and sotrovimab (a monoclonal antibody treatment).
STATUS: open to recruitment
Visit: www.recoverytrial.net
Recovery-RS (respiratory support)
This is a national clinical trial which aims to identify treatments that may be beneficial for adults hospitalised with suspected or confirmed COVID-19. It is for patients who need help to keep their oxygen levels high enough. Specifically, we are comparing two ventilation methods:
- Continuous Positive Airway Pressure (CPAP) – applies mild to high air pressure on a continuous basis through a tightly fitted mask
- Standard treatment – oxygen delivered via a normal face mask or tubes in the nose
TRIAL UPDATE: CPAP, compared with conventional oxygen therapy, reduced likelihood of intubation or death within 30 days of randomisation in hospitalised adults with acute respiratory failure due to COVID-19. There was no effect observed, compared with conventional oxygen therapy, with the use of High Flow Nasal Oxygen (HFNO).
Status: Closed to recruitment
Visit: https://warwick.ac.uk/fac/sci/med/research/ctu/trials/recovery-rs/
REMAP-CAP
This study will assess the most clinically effective treatments for adult patients admitted to an intensive care unit with both severe community-acquired pneumonia (CAP) and COVID-19. The treatment arm currently being tested in our hospitals is the anticoagulant domain (medicines that prevent blood clots).
TRIAL UPDATE: Tocilizumab and sarilumab have been shown to increase survival rates and decrease length of stay in ICU for patients with severe COVID-19.
Status: paused
Visit: https://www.remapcap.org/coronavirus
ACCORD2
ACCORD2 (which stands for ACcelerating COVID-19 Research & Development) is a new, Phase II clinical trial platform launched in the UK to fast-track research into potential treatments for COVID-19.
Funded by the Department of Health and Social Care and UK Research and Innovation, ACCORD has been made possible by government, academia and industry working together. In Leicester, we will play a key role in ACCORD2 through our NIHR Biomedical Research Centre, NIHR Clinical Research Facility and hospital colleagues working together.
The first medicine we shall test targets ‘interleukin 33’ (IL-33). The anti-IL-33 compound is being provided by the pharmaceutical company, AstraZeneca.
IL-33 is a type of protein called a cytokine, which is released by cells in the body in response to viral infections and tissue damage. It is thought that IL-33 may play a role in increasing the inflammatory response in the lungs of patients who are severely ill with COVID-19.
This trial will assess whether targeting IL-33 reduces the likelihood of disease progression in patients admitted to hospital with COVID-19 pneumonia. If the results of the trial show that the new medicine may be effective in patients with COVID-19, and safe for use, it will advance rapidly into a larger scale trial.
Status: study paused
Visit: ACCORD platform
PANCOVID
PANCOVID (Pregnancy And Neonatal outcomes in COVID-19) is an international study collecting information about women with suspected or confirmed SARS-CoV-2 infection in pregnancy and their neonates.
The aim of the study is to better understand the impact of COVID-19 on mothers and their babies. This information will be used to guide future methods of treatment and prevention.
Status: Open to recruitment
Visit: https://pan-covid.org/
EXCEED
EXCEED (Extended Cohort for E-health, Environment and DNA) looks at the causes of long-term health conditions by collecting information about genes and lifestyle.
We aim to understand why some people develop more severe COVID-19 than others, and the impact of the pandemic on long-term conditions. This will help develop new ways to prevent or treat COVID-19 and long-term conditions during and after the pandemic. Minority ethnic and migrant communities have had higher rates of COVID-19 hospital admissions.
Status: open to recruitment
Visit: www.exceed.org.uk
National age-stratified COVID-19 population seroprevalence
This survey is to understand the prevalence of COVID-19 in England among children under 18, over time and by geographic location. It does this by testing anonymised leftover blood or serum samples from routine investigations taking place in participating centres, such as Leicester’s Hospitals.
This information will be used to help predict the impact of coronavirus on health and social care services, as well as accurately monitor exposure and severity of the disease in different age groups.
Status: open to recruitment
Visit:
https://www.gov.uk/government/publications/national-covid-19-surveillance-reports/sero-surveillance-of-covid-19
GenOMICC
In the GenOMICC study we will be collecting blood samples from children who are admitted to ICU with COVID-19 and sending them to a laboratory, where the patient’s entire genome will be sequenced.
The results will be compared to genomes of people who have only mild symptoms or no symptoms at all. This may give researchers new insights as to why the virus affects people differently.
Status: open to recruitment
Visit: https://genomicc.org/
NHS CHECK
This study is designed to better understand the short and long term health and well-being of staff in the NHS – including students and volunteers – during the coronavirus pandemic.
Status: closed to new recruits in Leicester
Visit: www.nhscheck.org
DIAMONDS Search
This study aims to find RNA signatures in blood from people with severe infectious and/or inflammatory conditions, such as COVID-19. Leicester’s Hospitals is running this study in its children’s hospital as part of our COVID-19 research portfolio. The DIAMONDS team intend to matching RNA signatures to specific diseases and develop accurate new diagnostic tests, so clinicians could quickly identify the cause of a common symptom such as fever. This could be used in the rare condition called paediatric inflammatory multisystem syndrome, believed to be associated with COVID-19.
Status: open to recruitment
Visit:
https://www.nihr.ac.uk/covid-studies/study-detail.htm?entryId=278651
CAPACITY
While most patients with COVID-19 present with respiratory symptoms, early reports show that some of these patients develop cardiovascular problems. In some patients, cardiovascular symptoms are even the first sign of COVID-19. There is also some evidence that people with a history of cardiovascular disease might be at a higher risk of complications from COVID-19. Currently, insufficient evidence is available to guide monitoring of cardiovascular complications and treatment decisions in COVID-19 patients with a history of cardiovascular disease. This study will seek to shed light on how frequently cardiac complications arise in patients with COVID-19 and whether a pre-existing history of heart disease is associated with more complications.
Status: open to recruitment
Visit: https://capacity-covid.eu/
HEAL-COVID
This is a clinical trial to compare different treatments to determine whether they can improve the longer-term outcomes for patients who have been hospitalised due to COVID-19.
Patients will be asked if they would like to take part in the study shortly before they are discharged home, and will be randomly allocated to receive:
- Apixaban, an anti-coagulant or “blood thinner”, twice a day for 2 weeks; or
- Atorvastatin, a statin with anti-inflammatory properties, once a day for 12 months; or
- The usual standard care offered by their hospital, as appropriate to their symptoms and conditions
STATUS: open to recruitment
Visit: https://www.heal-covid.net/
Cov-Boost
We are one of 18 sites in the UK recruiting to this study, who are trying to find out which vaccines against COVID-19 are most effective as a booster vaccination, depending on which vaccine was used to provide the initial prime-boost (two dose) course. We will be enrolling men and women over the age of 30 who received their initial prime-boost course of vaccination against COVID-19 in December 2020 or January 2021 and their second vaccination by the end of March 2021. We are particularly keen to hear from people over the age of 70.
UPDATE: Six of the vaccines tested on this study were shown to provide an immune response.
STATUS: closed to recruitment; study in follow-up. Phase 2 of COV-BOOST is due to open in January 2022.
Visit: https://www.covboost.org.uk/participate-leicester
COVID-Nurse
This is the first, and currently only, robust clinical trial of nursing care for patients infected with COVID-19 in the world. The trial, called COVID-NURSE, tests a clinical nursing care protocol, based on a combination of published evidence and practice-based innovations from nurses themselves. Nurses and patients have ‘co-created’ the COVID-NURSE intervention from this combination of evidence.
STATUS: closed to recruitment; results and guidelines available here
Visit: http://blogs.exeter.ac.uk/covid-nurse/
